Apexigen, BMS to combine CD40 and anti-CSF-1 drugs with Opdivo in new study

Apexigen and BMS hope a combination of CD40 activation and CSF-1 inhibition can turn cold tumors hot, triggering T cell responses in the tumor microenvironment. (Pixabay)

Apexigen has begun collaborating with Yale Cancer Center on an early-stage clinical trial that combines the biotech’s APX005M CD40 activator with Bristol-Myers Squibb’s Opdivo and cabiralizumab, an investigational anti-CSF-1 antibody, in patients with advanced solid tumors.

The phase 1/1b study plans to enroll 120 patients with metastatic non-small cell lung cancer, metastatic melanoma and renal cell carcinoma whose disease has progressed following an anti-PD-1/PD-L1 therapy.

BMS, looking for new ways to extend the effectiveness of its flagship checkpoint inhibitor, will provide a portion of the funding, as well as supply Opdivo (nivolumab) and cabiralizumab, which is being co-developed with Five Prime Therapeutics in a $1.74 billion deal.

According to the San Carlos, California-based Apexigen, preclinical data and mouse model studies from Yale researchers and others have shown treatment with a combination of CD40 activation and inhibition of the CSF-1 receptor can modify tumor-associated macrophages and activate T cells in the tumor microenvironment and launching an immune response.

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“There is an urgent need to find effective therapies for the growing number of patients who have not responded to checkpoint inhibitors,” Apexigen President and CEO Xiaodong Yang, M.D., said in a statement.

“CD40 has a fundamental role in the activation of both innate and adaptive immunity, and we believe that CD40 activation by APX005M will become a key component of a number of promising new I-O therapeutic regimens for treating cancer patients,” Yang said.

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Apexigen recently brought on BMS’ former director of in vivo studies, Frances Rena Bahjat, as its new VP of discovery research. Apexigen’s discovery platform focuses on rabbit monoclonal antibodies and mutational lineage-guided humanization, producing seven candidates including its lead program, APX005M, which is also being studied in a phase 2 trial at the University of California, San Francisco.

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